MedDataX Logo

Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

NCT ID: NCT00144287

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

The safety assessment will be performed by evaluating:

* The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
* The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.

The efficacy assessment will be performed by evaluating:

* The quantity of HIV-1 RNA
* The CD4 cell count.

Study Hypothesis:

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

Comparison(s):

N.A.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tipranavir/Ritonavir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
2. Age \>= 18 years
3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
4. Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion Criteria

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
2. Required use of restricted medications
3. Female patients of childbearing potential who:

* Have a positive pregnancy test at baseline or
* Are breast feeding.
4. Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
5. Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
6. Hepatic impairment(\*) evidenced by the following baseline laboratory findings:

* AST or ALT \>5X upper limit of normal (ULN) or total bilirubin \>3.5X ULN or
* AST or ALT \>2.5X ULN and total bilirubin \>2X ULN

(\*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Pharma GmbH & Co. KG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Epimed GmbH

Berlin, , Germany

Site Status

Universitätskliniken Charité

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Klinikum der Ruhr-Universität Bochum

Bochum, , Germany

Site Status

Medizinische Universitätsklinik Bonn

Bonn, , Germany

Site Status

Krankenhaus der

Cologne, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

Universitätsklinik Köln

Cologne, , Germany

Site Status

Klinikum Dortmund g GmbH

Dortmund, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Duisburg, , Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

Universitätsklinik Erlangen-Nürnberg

Erlangen, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Klinikum der J.-W.-Goethe-Universität

Frankfurt am Main, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

Klinikum der Justus-Liebig-Universität

Giessen, , Germany

Site Status

ifi Institut für Interdisziplinäre Infektiologie

Hamburg, , Germany

Site Status

IPM Study Center GmbH

Hamburg, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

Med. Hochschule Hannover

Hanover, , Germany

Site Status

Universitätsklinik des Saarlandes

Homburg/Saar, , Germany

Site Status

Universitätsklinikum im

Kiel, , Germany

Site Status

Städtisches Krankenhaus Kemperhof

Koblenz, , Germany

Site Status

Städtisches Klinikum St. Georg

Leipzig, , Germany

Site Status

Johannes-Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Medizinische Poliklinik

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

Klinik und Poliklinik für Neurologie

Münster, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Oldenburg, , Germany

Site Status

Klinium Natruper Holz

Osnabrück, , Germany

Site Status

Klinikum Salzgitter GmbH

Salzgitter, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Stuttgart, , Germany

Site Status

Medizinische Universitätsklinik Ulm

Ulm, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wuppertal, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1182.68

Identifier Type: -

Identifier Source: org_study_id